The opinion aims to assess whether there are any health concerns linked to the use of MoM implants in arthroplasty. It also seeks, where possible, to provide indications on design of the devices, on patient groups and to identify needs for further research.

New version of the Blue Guide 2014. What is new?

In April 2014, the European Commission finally published the revised Blue Guide on the implementation of EU products rules (The “Blue Guide”). This updated version of the Blue Guide reflects the modernization and harmonization of the EU legislative framework for marketing of products.

The Concept and Objectives of the revision

The New Blue Guide updates the previous edition of the Blue Guide (Guide to the implementation of the directives based on the New Approach and the Global Approach), published in 2000. Since then, as it is stated in the new Blue Guide, it has become one of the main reference documents explaining how to implement the legislation based on the New Approach, now covered by the so-called New Legislative Framework (NLF). Read more

The Package of measures known as the “New legislative framework” was published in the Official Journal on 13 August 2008. The measures are designed to help the internal market for goods work better and to strengthen and modernize the conditions for placing a wide range of industrial products on the EU market.

Obelis, a Regulatory Partner for Horizon 2020 projects

Obelis is honored to announce its participation in the largest European project for Research and Innovation run by the European Commission – Horizon 2020. This, in continuous to Obelis’ activities under the FP7 program.

What is Horizon 2020?

Horizon 2020 represents the largest European project for Research and Innovation with a budget of almost 80 Billion euros. The program, available for 7 years (2014-2020) is a financial instrument used by the European Commission order to ensure global competitiveness across the entire European Market.

Being an extension of the earlier FP7 (7th Framework Program for Research and Technological Development), Horizon 2020 aims, as well, at increasing the number of jobs and at maintaining leadership in the global knowledge economy, but more than that, it promises a more market oriented approach, by taking innovative ideas from the lab to the market.

The Horizon 2020 program would normally include the following process:

Proposal Submission

Allocation of Partners

Experts Evaluation

Grant Agreement

What is Obelis Role?

Obelis partners with different project leaders, all across the European Union towards supporting their projects with advice and consultancies on the correct regulatory and compliance process with EU legislation.

Obelis role in such projects would normally focus on the following objectives:

Setting up the project technical documentations, towards compliance with the essential requirements of the applicable EC legislations.

Future Expectations

Providing CE Marking advisory services on medical devices for over 25 years, allowed Obelis to not only support the medical device industry at product launch but also at the initial stages of design and development.

Being a continuous supporter of the single market, Obelis has also been a strong promoter of the EU Research and Innovation programs. As with previous research projects, Obelis aims to continue providing regulatory advice to Horizon 2020 projects, yet to come.

If you would like to know more on the Horizon 2020 program, please do not hesitate to contact us.

Irish Authorities restructure

On July 1st 2014, the Irish national regulator for medicines, medical devices, cosmetics and other health products will be named HPRA (Health Products Regulatory Authority) instead of its former name – IMB (Irish Medicines Board)

Why now?

According to the HPRA, the new name more clearly reflects the wider scope of functions and responsibilities assigned to the regulatory authority in reference to its initial status established in 1996, towards regulating only human & veterinary medicines.

As such, the HPRA is officially responsible to regulate the following range of sectors on the Irish market, including: cosmetics, medical devices, controlled drugs, clinical investigations and more.

Principle activities of HPRA towards Cosmetics

Under the competencies/services of the HPRA:

Operating an effective and broad reaching market surveillance program

Investigation of safety concerns arising during cosmetic product use.

Inspection of manufacturers and distributors of cosmetic products.

Participation in international activities, including relevant EU working groups.

Generation of Certificates of Free Sale.

How will HPRA monitor Cosmetics?

Under its market surveillance activities, the HPRA shall conduct annual programs for products being sampled for analytical testing and review. HPRA market surveillance activities will focus on products which were reported to lead to serious undesirable effects (SUEs) or products reported through the EU rapid alert network (RAPEX) to all EU Member states.

Cooperation with Responsible Persons

The HPRA will work closely with Responsible Persons towards the key requirements of which may include but are not limited to:

Labeling

Notification

Product information file (PIF)

Good Manufacturing Practices (GMP)

Communication of serious undesirable effects

Sampling, analysis and Traceability within the supply chainCorrective actions in the event of cosmetic product non-compliance

The HPRA will work closely with Responsible Persons towards corrective and/or preventative measures to ensure consumer safety – such as:

A change in usage instructions;

Updates to product labeling;

Additional precautions for use;

Re-formulation;

Product recall or withdrawal;

Future Expectations

The HPRA will continue to operate under the regulatory framework of the European Cosmetic Regulation EC 1223/2009 towards enforcing it by monitoring the safety and compliance of cosmetic products. The HPRA will rely on effective and pro-active post market surveillance activities which will focus on sampling and analysis alongside a close work with Responsible Persons.

If you would like to know more on the Irish Health Products Regulatory Authority, please contact us.

The new measures were adopted as a part of the European Commission Joint Plan for Immediate Action, whose aim is to restore confidence in the Medical Devices sector following the Poly Implant Prothèse breast implant scandal.

What’s new in the regulation:

The Regulation consists of 10 Articles and 2 annexes.

The main novelties of this legislation are focused on the:

Introduction of a joint assessment procedure for the designation of Notified Bodies (EU bodies accredited to certify theCE marking), involving experts from the European Commission and from the designating authorities of other Member States. Moreover, the designation of NB becomes limited in time and needs to be regularly renewed.

Clarification of the essential knowledge and experience requirements for the staff of the NB.

Obligation to conduct regular monitoring and surveillance of NB in order to ensure that they are constantly compliant with the relevant Organizational and General Requirements identified in Annex II of the Implementing Regulation.

Possibility to perform unannounced on-site audits of NB.

Exchange of experience between designating authorities on relevant questions concerning the interpretation of provisions of Directive 90/385/EEC and Directive 93/42/EEC.

Enhanced cooperation between the European Commission and National Competent Authorities (the Assessment Reports shall be made available, upon request, to all other Member States).

Impact on the Authorized Representative

The Implementing Regulation 920/2013 reaffirms the distinction of roles between Notified Bodies and Authorized Representatives: Article 1.3 of Annex I (on the Interpretation of criteria set out in Annex 8 to Directive 90/385/EEC and in Annex XI to Directive 93/42/EEC) explicitly states that “Conformity assessment body, its top management and the personnel responsible for carrying out the conformity assessment tasks shall not offer or provide or have offered or provided, during the last three years, consultancy services to the manufacturer, his authorized representative, a supplier or a commercial competitor”.

The new Regulation, therefore acknowledges the role of the European Authorized Representative as provider of consultancy services and regulatory updates to MD manufacturers.

Expectations for the future implementation

The implementation of the provisions contained in Regulation 920/2013 will ensure a better supervision of Notified Bodies and of their activities and an improved flow of information between the competent authorities and Notified Bodies both at national and EU level.

If you would like to know more on the new Regulation on the Designation and Supervision of Notified Bodies, please contact us

Devices must bear a CE marking and have a declaration of conformity for the RoHS Directive from:

22nd of July 2014 for Medical Devices.

22nd of July 2016 for In-Vitro Diagnostic Medical Devices.

NOTE: A single CE marking and declaration are acceptable. (You will need to explain the dual meaning of the CE marking in the instructions for use and clarify that, if used, the Notified Body number only applies to the MDD or IVDD related issues.)

Authorized Representative:

Means any natural or legal person established within the European Union who has received a written mandate from a manufacturer to act on their behalf in relation to specified tasks (RoHS 2011/65/EU Article 2.7);

A Non-EU manufacturer (not having a registered address in the EU) will be required to nominate an Authorized Representativein order to obtain the CE marking.

Exemptions:

Cables and spare parts needed for the repair or reuse of devices may continue to be distributed for devices placed on the market prior to the transition date.

Exemptions available to all devices are listed in Annex III. Specific exemptions for medical devices are listed in Annex IV.

Exemptions for medical devices will be valid for up to 7 years.

Requests for exemptions:

Must be filed with the Commission and include all information listed in Annex V. Most notably, the request must include an analysis of possible alternative substances, materials or designs.

Renewals must be requested at least 18 months before the existing exemption expires.

Labeling:

The labeling requirements are likely to have been already addressed by MDD or IVDD requirements. However, a review of the requirements in Articles 7.g, 7.h9.d and 10.a will be needed for confirmation.

Record Retention:

Records must be retained for 10 years after a device is placed on the market. Note that this may be longer than required by the MDD 93/42/EEC or IVDD 98/79/EC.

Records to retain include technical documentation confirming compliance with the RoHS Directive and a register of non-conforming products and product recalls.

Regulatory updates on the standard EN 980

The European Commission (EC) has published on January 24th, 2013, the list of EU Harmonized standards applicable to medical devices. It appears that two harmonized standards have gone missing: EN 980 and EN ISO 15223-1 are not on the list. Those standards are very important for medical devices manufacturers, as their goal is to harmonize the rules regarding symbols used on labels (in addition to the language requirements).

The Commission explained that the disappearance of EN 980 was a mistake: EN ISO 15223-1 was supposed to be harmonized and to eventually replace EN 980 all together. However, the Commission decided otherwise, as the EN ISO 15223-1 seemed not to provide an overall standard to the three medical devices directives – MDD 93/42/EEC, AIMDD 90/385/EEC & IVDD 98/79/EC).

Public workshop by EC on NEW medical device regulations

The NEW proposals for regulations for medical devices and in-vitro diagnostics medical devices, adopted by the European Commission last September (proposal 2012.541 & proposal 2012.542) were discussed at a public workshop held by the European Parliament’s Committee on the Environment, Public Health and Food Safety (ENVI), on February 26th 2013.

These NEW proposals are intended to replace the current MDD 93/42/EEC, AIMDD 90/385/EEC & IVDD 98/79/EC and to be adopted and accepted by the EU Parliament & the Council of European Union is (under most cases) under an Ordinary Legislative Procedure (OLP).

Obelis’ notification officers, in charge of the pre-market notification of medical devices & in-vitro diagnostic medical devices as European Authorized Representative Center (OEARC) of such Non-EU manufacturers, participated to this workshop to provide a summary of the main topics presented:

Ireland EU Presidency, to influence Medical Device Regulations

On January 1st 2013, Ireland took over the presidency of the Council of the European Union under the presidency trio of 2013-2014 (Ireland, Lithuania & Greece). Ireland presidency will be between, January 1st 2013 till June 30th 2013. This will be the 7th time Ireland holds this office and it coincides with the 40th anniversary of Ireland joining the European Union (1973).

Impact on the Authorized Representative by NEW medical device proposals

The new proposal on medical devices and the new proposal on in-vitro diagnostics medical devices as presented during the press conference of September 26th 2012, by the EU Commissioner for Health and Consumer Policy, John Dalli bring important changes to the role & responsibilities of the authorized representative.

Obelis officially welcomes NEW Proposals of European Medical Device Legislation

Obelis European Authorized Representative Center (O.E.A.R.C.), 24 years in business and operating as one of the largest regulatory centers in Europe today, providing CE marking advisory services and European Authorized Representative services – officially welcomes the new proposals for new regulations on medical devices and in-vitro diagnostics medical devices as presented during the press conference, by the EU Commissioner for Health and Consumer Policy, John Dalli.

Review of Press Conference on NEW Proposals of European Medical Device Legislation

With over 500,000 medical devices on the European market and the recent PIP fraud incident, amending the current European legal frame work on medical devices was inevitable;

On the 26th of September 2012, Mr. John Dalli, EU Commissioner for Health and Consumer Policy, presented in a 25 minute press conference of September 26th 2012, the main principles within the proposals for new regulations for medical devices and in-vitro diagnostics medical devices adopted by the European Commission.

Eucomed welcoming medical device proposals with reservations

Eucomed, the European medical technology industry association has expressed its welcome to the adoption of the proposals for new regulations for medical devices and in-vitro diagnostics medical devices by the European Commission.

Update on Medical Device Regulations in Switzerland

The European Economic Area (EEA) is formed by the 27 member states of the European Union as well as the 3 EFTA countries, Iceland, Norway & Lichtenstein (view map of the EEA ) – as such, one can wonder, what is the status of Switzerland within this league of nations and how medical devices are regulated in this market?

Commission Proposal for a NEW REGULATION on Medical Devices and In-Vitro Diagnostic Medical Devices

On 26th Sept, 2012 the Commission has adopted a Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and a Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on in vitro diagnostic medical devices as announced during the press conference by John DALLI, Member of the EC in charge of Health and Consumer Policy.

The EU Regulation 722/2012 on utilizing tissues of animal origin

The EU Regulation 722/2012 on AIMDD 90/385/EEC and MDD 93/42/EEC utilizing tissues of animal origin was published in the Official Journal L212 on 09 August 2012, entered into force on the 28 August 2012 and applicable from 29 August 2013. As a regulation, it does not need to be transposed into national legislations by the individual EU states.

NEW WEEE Directive’s Affects on Medical Devices

How does WEEE apply to Medical Devices?

As opposed to the WEEE Directive 2002/96/EC & 2003/108/EC, which states that Medical Devices (regulated under MDD 93/42/EEC, IVD 98/79/EC, AIMDD 90/385/EEC falling under WEEE do not require achieving any recycling collecting target, the repealing WEEE Directive 2012/19/EU tightens the legislation and sets tangible objectives:

From 13th August 2012: Medical Devices are subjects to a recovery target of 70% and a recycling target of 50%;

From 15th August 2015: Medical Devices are subjects to recovery target of 75% and a recycling target of 55% respectively;

From 15th August 2015: Medical Devices (falling under category 4: Large equipments) are subjects to recovery target of 85% and a recycling target of 80% respectively; and Medical Devices (falling under category 5: Small equipments) are subjects to recovery target o 75% and a recycling target of 55% respectively;

The above indicated objectives make all Medical Device manufacturers, distributors, vendors and consumers take the necessary steps, if necessary, to fulfill the new WEEE requirements.

Revision of the IEC 60601-1 Regarding Medical Devices, 3rd Edition

The International ICE 60601-1 standard and its 3rd revision regarding the safety and effectiveness of medical electrical equipment are of crucial importance to the manufacturers of such medical devices. More so since the 3rd revision will come into force starting the 1st of June 2012.

Manufacturers incorporating electric components to medical devices may find a dilemma when addressing the conformity to the 3rd edition of the IEC 60601-1, in reference to medical devices already on the distribution channel or such devices about to be shipped out of the factory. What does the standard mean? What do you have to do as manufacturers of medical devices and systems to still be able to distribute your products on the European Market come June 2012 (when the 3rd edition of IEC 60601-1 shall be fully applicable).

New Electronic Labeling for Medical Devices

A new Regulation (EU 207/2012) on electronic instructions for use of medical devices has been recently adopted by the European Commission and it will come into full force starting 1st of Marc 2013.

Apart from the CE marking affix requirements and the designation of a European Authorized Representative (EAR) for all non-EU manufactures of medical devices underlined by the MDD 93/42/EEC and AIMDD 90/385/EEC, the new Regulations brings several instructions for manufacturers on how to make available the electronic labels of products.

New Agency for Medical Device Registration in France

On April 29th 2012, France published in its official journal about the creation of a new agency, the National Agency for the Safety of Medicines and Health Products (MSNA), aimed to replace entirely its current regulatory agency, Afssaps, within a few months.

Animal by-products EU regulation on Medical and Cosmetic products

Regulation EC 1069/2009 and its implementing Commission Regulation 142/2011 – in effect as of 4th March, 2011 – lay down the public and animal health rules for animal-by-products (ABPs) and derived products to prevent and minimize risks to health deriving from these products.

By definition: ‘animal by-product’ means entire bodies or parts of animals, products of animal origin or other products obtained from animals, which are not intended for human consumption (Article 3). These include: fallen stock on farms, wild animals when they suspected of being diseases, slaughterhouse waste, skins, feathers, blood, or meat, fish, milk and eggs when they are interned for human consumption. (Article 8, 9, 10);

Due to the increasing number of incidents, when serious diseases (TSE, BSE, swine fever) started to spread in a consequence of the lack of risk control, the preceding Regulation (EC 1774/2002) has been thoroughly revised. As a result, the current Regulation:

Gives a more comprehensive scope and more apparent framework to the Regulation;

Consequently, the Regulation provides a greater overall legal certainty for the given substance. It has an impact on any person or business using, disposing, storing, handling or transposing animal-by-products.

One the most significant change that the Regulation introduces is the concept of end point in the manufacturing of animal by-products, beyond which the processed products are no longer subject to the requirements of the Regulation, due to the eliminated potential risks via heat or chemical substances. (Article 5 /Rec.22). Consequently, certain finished products such as cosmetics, medical devices and in vitro diagnostic kits are excluded from the scope of Regulation 1069/2009 in this way to reduce operational burdens, e.g. labeling or record-keeping.

The following derived products may be placed on the European market, regulated by certain Community legislation other than that of Regulation 1069/2009 (see Article 33):

According to Article 34 importing, collecting animal-by-products for manufacturing the above mentioned devices, their respective Directives should be taken into account. Should not these Directives provide steps to control potential risks deriving from animal-by-products then Regulation 1069/2009 shall be applicable. However, intermediate products intended for the manufacture of medical products, veterinary medicinal products, medical device, active implement medical devices, in vitro diagnostic medical devices or laboratory reagent are subject to the obligations imposed by Regulation in question.

To conclude the above, Regulation 1069/2009 and Commission Regulation 142/2011 does not apply to finished products under the respective scopes of the:

Scope of MDD 93/42/EEC

Scope of AIMDD 90/385/EEC

Scope of IVDD 98/79/EC

Scope of Cosmetics under the 76/768/EEC and repealing regulation EC 1223/2009,

Since they are not considered as ‘animal by-products not intended for human consumption’. Therefore; they are not subjected to any veterinary checks under Council Directive 97/78/EC that lays down the principles governing the organization of veterinary checks on products entering the Community from third countries.

Regulation 1069/2009 and Commission Regulation 142/2011 does not apply to finished products under the respective scopes of the:

Scope of MDD 93/42/EEC

Scope of AIMDD 90/385/EEC

Scope of IVDD 98/79/EC

Scope of Cosmetics under the 76/768/EEC and repealing regulation EC 1223/2009,

Since they are not considered as “animal by-products not intended for human consumption”. Therefore; they are not subjected to any veterinary checks under Council Directive 97/78/EC that lays down the principles governing the organization of veterinary checks on products entering the Community from third countries.